- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03026686
Postpartum Readmission
Postpartum Preeclampsia Readmission
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Preeclampsia is a pregnancy-specific multisystem disorder of unknown etiology. The disorder affects approximately 10 percent of pregnancies worldwide constituting one of the greatest causes of maternal and perinatal morbidity and mortality worldwide. (1) Preeclampsia is defined by the new onset of elevated blood pressure after 20 weeks of gestation. It is considered severe if blood pressure is increased substantially or symptoms of end-organ damage (including fetal growth restriction) occur. There is no single reliable, cost-effective screening test for preeclampsia, and there are no well-established measures for primary prevention. Management before the onset of labor includes close monitoring of maternal and fetal status. Management during delivery includes seizure prophylaxis with magnesium sulfate and, if necessary, medical management of hypertension. Delivery remains the ultimate treatment.
Preeclampsia leads to eclampsia. Symptoms of preeclampsia include: weight gain, headaches, right upper quadrant pain, swelling of hands and feet, and vision problems Symptoms of eclampsia include: muscle aches and pains, seizures, severe agitation, unconsciousness
Current obstetric treatment in the United States has resulted in a shift of eclampsia toward the postpartum period, with most cases being seen as late post partum. During the post partum period a patient's blood pressure peaks around 3-6 days post delivery, however most patients are discharged home by 48 hours. This results in re-admission to the hospital for some women. The investigator's goal is to review and evaluate women who have been readmitted for a preeclampsia or eclampsia episode during the post partum period to assess if there are preceding signs or symptoms leading to her re admission.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Women who labored and delivered at a single hospital Readmitted (within 6 weeks post partum (PP) or less)to the hospital for hypertension disorder, with or without hypertension (HTN in pregnancy), gestational hypertension (gHTN), pre eclampsia (PreE), severe pre eclampsia (sPreE), HELLP ("HELLP" is an abbreviation of the three main features of the syndrome: Hemolysis. Elevated Liver enzymes. Low Platelet count.).
Controls Group with PreE, not readmitted or No PreE
Exclusion Criteria:
- Hospital readmission for other complications.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
readmit
women who were re-admitted in the post partum period for a hypertensive disorder
|
|
Controls
women with similar risk factors but did not require readmission
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
hypertension
Tidsramme: 1 year
|
compare these two groups during the antepartum period, labor, delivery and post partum course for possible preceding signs (blood pressures) of those at risk for re admission for hypertensive disorders.
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 24998
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Postpartum hypertension
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National Cheng-Kung University HospitalAfsluttetPostpartum hypertension | Hypertensive forstyrrelser under graviditet (HDP)Taiwan
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Federal University of ParaíbaAfsluttetForhøjet blodtryk | Graviditetsinduceret hypertension i postpartum | Postpartum præ-eklampsiBrasilien
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Anna Stanhewicz, PhDAktiv, ikke rekrutterende
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ResQ Medical LtdRekrutteringFeasibility Klinisk undersøgelse af Alma-systemet til behandling af primær postpartum blødning (EVE)Postpartum blødning (primær) | Postpartum blødning (PPH) | PPHIsrael, Forenede Stater
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Columbia UniversityAfsluttetPræeklampsi efter fødslen | Hypertensiv nødsituation | Postpartum Graviditet-induceret hypertension | Graviditetsinduceret hypertension i postpartumForenede Stater
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Icahn School of Medicine at Mount SinaiAfsluttetHypertension under graviditet | Hypertension i postpartumForenede Stater
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Cedars-Sinai Medical CenterAfsluttet
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Alexander HarrisonIkke rekrutterer endnuPræeklampsi postpartum | Svære præeklampsiForenede Stater
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Yale UniversityPatient-Centered Outcomes Research InstituteRekrutteringPostpartum hypertensionForenede Stater
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University of California, Los AngelesRekrutteringPostpartum hypertension (PPHT)Forenede Stater